Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Dr. Heidi Overton And The FDA: An Outsourcing Perspective

There’s something sadly predictable about negative media reaction to a woman whose professional accomplishments ought to command attention before anything else, writes Chief Editor Louis Garguilo. "But what interests others heading into the Heidi Overton nomination process for FDA Commissioner is whether she can guide the FDA to help us get medicines developed, manufactured, and approved. So what kind of FDA does the outsourcing supply chain need?"

GUEST COLUMNISTS

You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.

PHARMA OUTSOURCING WHITE PAPERS

The 5 Ws Of A Human Factors Strategy
A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

Using Client Centricity As Fuel For Innovative Biologics Development And Manufacturing Solutions
Complex biologics require flexible development, advanced analytics, and quality by design. Learn how collaborative bioprocessing reduces risk, enables efficient scale‑up, and supports clinical success.
Precision In Miniature: Optimizing Multiparticulate Formulations For Pediatric Oncology
When an oral liquid formulation of crizotinib failed pediatric trials due to intolerable taste and irritation, a multiparticulate approach offered a technically demanding but viable path forward.
Redefining OSD Development Through Foresight And Innovation
From early formulation challenges to scale-up and commercial readiness, proactive planning and integrated capabilities help teams anticipate risks, accelerate decision-making, and maintain momentum across development.
Guiding Principles For Process Development And IND Readiness
Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.
Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.